(174 days)
Not Found
No
The summary describes image processing and computational modeling for pre-operational planning, but there is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with AI/ML development.
No
The device is intended for preoperational planning and computational modeling of neurointerventional devices, not for direct treatment or therapy.
No
The "Device Description" section explicitly states, "It is not intended for diagnosis." The "Intended Use / Indications for Use" section also notes, "Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition," further indicating it's not for diagnosis.
Yes
The device description explicitly states "The AneuGuide software is a medical device intended to provide a 3D view..." and details its functionalities as software workflows operating on imported DICOM images. There is no mention of accompanying hardware components required for its primary function. While it interacts with images from a hardware modality (3D rotational angiography) and models a hardware device (Pipeline Flex), the device itself is presented as a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- AneuGuide's Function: AneuGuide operates on medical images (3D rotational angiography) of the patient's intracranial vessels. It performs image processing, visualization, and computational modeling for preoperational planning and sizing of neurointerventional devices. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for "visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions" and "computational modeling the placement of neurointerventional devices." It explicitly states it is "not intended for diagnosis."
Therefore, AneuGuide falls under the category of medical imaging software or surgical planning software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures . - Automatic centerline detection - . Visualization of X-ray based images for 2D review and 3D reconstruction - . Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
Product codes (comma separated list FDA assigned to the subject device)
PZO
Device Description
The AneuGuide software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the flow diverters (FD) in the artery to be treated through endovascular surgery.
AneuGuide is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area. Also, it allows to pre-operationally estimate the size of flow diverter devices.
AneuGuide is composed of the following analysis workflows: image loading, selection of the volume of interest (VOI), segmentation threshold adjustment, reconstruction, selection of the region of interest (ROI), selection of the vessel inlet, generation of centerline, initializing the flow diverter, and sizing the flow diverter.
The flow diverter supported by the software is the Pipeline Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA: P100018/S015), which is an FDA-approved neurointerventional device. AneuGuide software has a "moderate" level of concern. It is intended only for preoperational planning. It is not intended for diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D rotational angiography, X-ray based images
Anatomical Site
intracranial vessels, cerebral blood vessels (implied from predicate)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
- Tests of importation of DICOM images.
- Patient management tests.
- Tests of image display and processing.
- Functioning tests for visualization of anatomic reconstruction.
- Report creation and visualization tests.
- Cybersecurity tests.
All tests have passed and demonstrate that the software is designed to meet the software requirements and functions as intended.
Performance Testing - Bench: The computational modeling of the Pipeline Flex Embolization Device was tested through two tests:
- Using silicone phantoms representative of patients presenting with intracranial aneurysms to compare the in vitro and virtual placement of the flow diverter.
- Validation study of the AneuGuide performance comparing the simulated deployed length of the Pipeline Flex Embolization Device with its implanted length in patients with intracranial aneurysms.
These validation tests allow to evaluate the performance (error) of the AneuGuide in calculating the deployed length of the Pipeline Flex Embolization Device after implantation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
June 1, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
ArteryFlow Technology Co., Ltd. Jianping Xiang, Ph.D. General Manager 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China
Re: K213838
Trade/Device Name: AneuGuide Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: PZO Dated: April 25, 2022 Received: May 2, 2022
Dear Dr. Xiang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213838
Device Name AneuGuide
Indications for Use (Describe)
AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as:
- Segmentation of neurovascular structures .
- Automatic centerline detection
- . Visualization of X-ray based images for 2D review and 3D reconstruction
- . Placing and sizing tools
- Reporting tools
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K213838: 510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: ArteryFlow Technology Co., Ltd. Address: 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China Phone Number: +86-571-86772567 Primary correspondent: Jianping Xiang, PhD, General Manager Email: jianping.xiang@arteryflow.com Secondary correspondent: Ashley Fu, RA Specialist Email: fang.fu@arteryflow.com Date of preparation: April 25, 2022
2. Device Information
Trade/ Device Name: AneuGuide
Common Name: Radiological Image Processing Software
Regulatory Class: Class II
Regulation Description: Medical Image Management and Processing System, Software for Visualization of Vascular Anatomy and Intravascular Devices
Regulation number: 892.2050
Classification Product Code: PZO
3. Predicate Device Information
Manufacturer: Sim&Cure Device Name: Sim&Size Regulatory Class: Class II Regulation Number: 892.2050 Classification Product Code: PZO 510(k) number: K202322
4. Device Description
4
The AneuGuide software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the flow diverters (FD) in the artery to be treated through endovascular surgery.
AneuGuide is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area. Also, it allows to pre-operationally estimate the size of flow diverter devices.
AneuGuide is composed of the following analysis workflows: image loading, selection of the volume of interest (VOI), segmentation threshold adjustment, reconstruction, selection of the region of interest (ROI), selection of the vessel inlet, generation of centerline, initializing the flow diverter, and sizing the flow diverter.
The flow diverter supported by the software is the Pipeline Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA: P100018/S015), which is an FDA-approved neurointerventional device. AneuGuide software has a "moderate" level of concern. It is intended only for preoperational planning. It is not intended for diagnosis.
5. Intended Use / Indication for Use
AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices.
General functionalities are provided such as:
- Seqmentation of neurovascular structures
- Automatic centerline detection
- Visualization of X-ray based images for 2D review and 3D reconstruction
- Placing and sizing tools
- Reporting tools
Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
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6. Comparison of Technological Characteristics
A comparison of the technological characteristics of the predicate and subject devices is provided in the table below.
| Characteristic | Predicate device | Subject device |
|---|---|---|
| Sim&Size | ||
| K202322 | AneuGuide | |
| K213838 | ||
| Indications for Use | Sim&Size enables visualization of | |
| cerebral blood vessels for preoperational | ||
| planning and sizing for neurovascular | ||
| interventions and surgery. Sim&Size also | ||
| allows for the ability to computationally | ||
| model the placement of | ||
| neurointerventional devices. General | ||
| functionalities are provided such as: | ||
| Segmentation of neurovascular structuresAutomatic centerline detectionVisualization of X-Ray based images for 2D review and 3D reconstructionPlacing and sizing toolsReporting toolsInformation provided by the software is | ||
| not intended in any way to eliminate, | ||
| replace or substitute for, in whole or in | ||
| part, the healthcare provider's judgment | ||
| and analysis of the patient's condition. | AneuGuide enables visualization of | |
| intracranial vessels for preoperational | ||
| planning and sizing for neurovascular | ||
| interventions. AneuGuide also allows for | ||
| the ability to computationally model the | ||
| placement of neurointerventional devices. | ||
| General functionalities are provided such | ||
| as: | ||
| Segmentation of neurovascular structuresAutomatic centerline detectionVisualization of X-Ray based images for 2D review and 3D reconstructionPlacing and sizing toolsReporting toolsInformation provided by the software is | ||
| not intended in any way to eliminate, | ||
| replace or substitute for, in whole or in | ||
| part, the healthcare provider's judgment | ||
| and analysis of the patient's condition. | ||
| Interface to Image | ||
| Sources | DICOM Image Data | DICOM Image Data |
| Import of Patient Data | Manual through keyboard/mouse, | |
| automatic import with image file, study | ||
| creation list | Same | |
| List Image | ||
| Functionality | Deleting, anonymizing, search | Same |
| Image Processing | Segmentation by user with clinician | |
| review and comment | Same |
| Table 1. General Comparison | ||
|---|---|---|
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| 3D Assessment | 3D assessment based on 3D model of the
simulated device inside the vessels | Same |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Image and 3D Display | Orthogonal, color volume rendering, 2D
slide review, active presets, 3D view of
assemblies of devices | Same |
| DICOM Support | Read DICOM images from 3D rotational
angiography stations | Same |
| Computer OS
Compatibility | MS Windows and Mac OS | Mac OS |
| Data
Interchange/Transfer
Method | Transfer by physical media, i.e. USB
memory stick and Scanner Workstations
(retrieve function only) | Transfer by physical media, i.e. USB
memory stick |
| Output File Format | Local openGL rendering | Local VTK rendering |
| Preoperational
Planning | Yes | Yes |
| Patient Contact | No | No |
| Human Intervention
for Interpretation of
Images | Yes | Yes |
| Implantable Medical
Device (IMD)
Database | - Pipeline™ Flex Embolization Device
(Micro Therapeutics, Inc. d/b/a ev3
Neurovascular, PMA number
P100018/S015)
- Woven EndoBridge (WEB) Aneurysm
Embolization System (MicroVention, Inc.,
PMA number P170032) - Surpass Evolve Flow Diverter System
(Stryker Neurovascular, P170024/S003). | - Pipeline™ Flex Embolization Device
(Micro Therapeutics, Inc. d/b/a ev3
Neurovascular, PMA number
P100018/S015) |
| Fusion correction | Automatic and manual | Manual |
7. Performance Data
The following performance data were performed on AneuGuide in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided
7
as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The software for this device was considered as a "moderate" level of concern, since prior to mitigation of hazards, a failure of the software device could result in minor injury to a patient.
The following performance tests were conducted:
- Tests of importation of DICOM images.
- Patient management tests.
- Tests of image display and processing.
- Functioning tests for visualization of anatomic reconstruction.
- Report creation and visualization tests.
- Cybersecurity tests.
All tests have passed and demonstrate that the software is designed to meet the software requirements and functions as intended.
Performance Testing - Bench
The computational modeling of the Pipeline Flex Embolization Device was tested through two tests:
- Using silicone phantoms representative of patients presenting with intracranial aneurysms to compare the in vitro and virtual placement of the flow diverter.
- Validation study of the AneuGuide performance comparing the simulated deployed length of the Pipeline Flex Embolization Device with its implanted length in patients with intracranial aneurysms.
These validation tests allow to evaluate the performance (error) of the AneuGuide in calculating the deployed length of the Pipeline Flex Embolization Device after implantation.
8. Conclusion
The AneuGuide has the same intended use and indications for use as the predicate device Sim&Size.
Verification and validation testing have produced results consistent with design input requirements. During the development, potential hazards were controlled by the risk management report, including risk analysis, risk mitigation, verification and validation.
ArteryFlow Technology concludes that the AneuGuide, intended for preoperational planning but not for diagnosis, is as safe and effective as the predicate device. The differences between the subject and predicate devices do not raise new questions of safety and effectiveness.